Photon/Proton Radiation Therapy for Oropharyngeal Cancers

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00797446

Acronym

OP01

Enrollment

Registered

2008-11-25

Start date

2007-09-30

Completion date

2015-07-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Cancers

Keywords

Oropharyngeal, cancer, proton, radiation, outcomes

Brief summary

The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Detailed description

This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue). * Stage-grouping: * Stage I (T1N0) * Stage II (T2N0) * Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node * Unfavorable stage III and selected stage IV (any T, N2c/N3) * Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies. * Will receive treatment with proton radiation.

Exclusion criteria

* Evidence of distant metastasis. * Previous irradiation for head and neck cancer.

Design outcomes

Primary

Measure	Time frame
Collect and analyze morbidity outcomes: incidence of xerostomia	From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary

Measure	Time frame
Collect and analyze tumor control outcomes.	From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Countries

United States

Outcome results